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However , in practice , patients often present to their GP with sleep data from fitness trackers , in the hope that this will assist medical decision-making . Clinical discretion is advised .
Some consumer-facing devices also ‘ toe the line ’ by presenting sleep data in a way that could be used to infer sleep disorder symptoms . For example , some fitness trackers provide a ‘ breathing index ’ or similar metrics , which could be used to infer sleep-disordered breathing ( that is , mainly defined by an apnoea-hypopnoea index ). Another example is commonly available online digital sleep programs that broadly claim to improve sleep health , but may at face-value appear to be treatments for insomnia ( for example , CBT-I ).
It is becoming increasingly common for devices to come up in the conversation with GPs , and this is often difficult to manage . 45 Given the plethora of sleep-related digital devices , apps , programs and tools that are available , clinical discretion is often required to identify appropriate digital tools for different patient presentations . This requires consideration of the potential benefits , risks and evidence .
Physicians may have limited knowledge about the specific devices , meaning that it is difficult to make informed on-the-spot decisions about the usefulness of the information these devices provide during consultations . For this reason , the TGA recommends searching the Australian Register of Therapeutic Goods ( ARTG ) and / or the manufacturer ’ s website for information on the safe use of the SaMD . 44 In February 2021 , the TGA proposed a new regulatory framework to govern the use of SaMDs . Under this framework , SaMDs fall into four broad categories of therapeutic use ( see box 4 ).
Within each of these categories , risk levels are further assigned ( that is , Class I , Class IIa , Class IIb , Class III ), where the higher classification confers a greater risk of public harm and is therefore subject to higher levels of regulatory scrutiny .
46 , 47
Table 1 provides an overview of this regulatory framework across the categories of SaMDs .
For consumer devices that are not classed as SaMDs , information can only be sought from the manufacturer directly . While the suitability of technologies that report on sleep for clinical practice is often difficult to ascertain , evidence is continuing to emerge to support the implementation of at least some digital sleep health approaches into routine clinical practice .
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IMPLEMENTING EVIDENCE- BASED DIGITAL SLEEP HEALTH INTERVENTIONS IN PRIMARY CARE
THERE has been a rapid increase in
evidence-based digital sleep health education resources , assessment tools and interventions that may prove useful for GPs . Given the high prevalence of sleep problems managed in general practice , 1 appropriate use of these digital tools has the potential to rapidly improve the efficiency and quality of patient sleep healthcare .
For example , GPs can use digital tools to access on-demand information about sleep disorders , communicate tailored sleep health information
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Figure 4 . Patients are increasingly using fitness trackers . |
Figure 5 . Digital resources . |
Box 4 . TGA categories of therapeutic use of SaMDs
• Provides a diagnosis or screens for a disease or condition .
• Monitors the state of progression of a disease or condition , or the parameters of a person with a disease or condition .
• Specifies or recommends a treatment or intervention .
• Provides therapy through the provision of information .
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to patients via email or text-messages , assist in identifying patients with potential sleep disorders from clinical records , facilitate standardised assessment of common sleep disorders before or during patient consultations , provide information on nightly self-report or measured sleep / wake data and treatment adherence , and access interventions such |
as digital CBT-I that would otherwise incur a high cost and / or long delays in accessing treatment . 48-51
Figure 7 outlines a potential sleep health pathway for general practice .
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A NEW INTERACTIVE ONLINE PRIMARY CARE SLEEP HEALTH RESOURCE
THE National Centre for Sleep Health
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Services Research and the Australasian Sleep Association ( ASA ) have developed and published a comprehensive sleep health resource specifically for
49 , 52 primary care ( see figure 8 ).
The resource provides on-demand information on the presenting symptoms , assessment , diagnosis , referral and treatment of insomnia and OSA in general practice . Brief standardised questionnaires can be used to assess for insomnia and a high-risk of sleep apnoea in the general practice setting . MBS criteria and recommendations on
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patient suitability for GP referral for an overnight home-based or laboratory-based sleep study are provided . Through a Commonwealth-funded program , the ASA is presently conducting qualitative interviews with GPs to understand the ways that this new online resource can facilitate care of patients with sleep health problems before , during and after patient consultations , and as a GP education resource . The Australian Government has also created Head to Health , a free online resource to assist doctors and patients to select an appropriate digital mental health intervention based on the presenting symptoms . |
CASE STUDIES
Case study one
PRIYA is a 42-year-old woman who
presents to her GP with a long-standing history of anxiety . Her anxiety has worsened over the past four months because of persistent sleep
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image from Search resources | Head to Health
difficulties , especially with waking during the night and not being able to get back to sleep . Priya reports that she wakes for long periods ( typically hours ) during the night and cannot get back to sleep . She feels increasingly fatigued during the day and has trouble concentrating . Priya also feels that her children ( a 12-year-old daughter and an eight-year-old son ) are not getting enough attention , as she is too tired during the day .
In the past , Priya was prescribed escitalopram 10mg daily for her anxiety but did not like taking it because it made her feel dizzy . She is reluctant to take medication for her sleep difficulties , as she is concerned about side-effects .
Priya has not had any recent infections or medical illnesses that would impact on her sleep disturbance and anxiety . She becomes more anxious when talking about her sleep difficulties .
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